Long-Term Follow-up of Tandem High-Dose Therapy With Peripheral Blood Stem Cell for Adults With High-Risk Age-Adjusted IPI Aggressive Non-Hodgkin's Lymphomas

Lymphoma Clinical Trial

— 073  

Official title:

Phase II Study Treatment of High Risk Non-Hodgkin's Lymphomas

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00869284
• Other study ID #: GOELAMS 073
• Secondary ID: no other identif
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2009
• Last updated: March 24, 2009
• Start date: October 1994
• Est. completion date: February 2009

Study information

• Verified date: March 2009
• Source: French Innovative Leukemia Organisation
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

Phase II multicenter pilot trial (073) evaluating tandem HDT with PBSC support in aa-IPI=3 untreated aggressive NHL.

Description:

High-dose chemotherapy; untreated aggressive non-Hodgkin's lymphoma; high-risk; peripheral blood stem cell support Patients were aged from 15 to 60 years

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: February 2009
• Est. primary completion date: July 1999
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 15 Years to 60 Years

Eligibility

Inclusion Criteria:

• patients aged from 15 to 60 years

• previously untreated

• histologically proven aggressive NHL

• high aa-IPI (equal to 3)

• proper underlying organ function

Exclusion Criteria:

• transformed low-grade, lymphoblastic, mantle-cell, or Burkitt's lymphoma

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Lymphoma, Non-Hodgkin

Intervention

Drug:
• CEEP regimen
cyclophosphamide 1200 mg/m² intravenously on day 1 (d1), epirubicin 100 mg/m² intravenously on d1, vindesine 3 mg/m² intravenously on d1 and prednisone 80 mg/m² orally or intravenously on d1-5, with two weeks intervals

Procedure:
• Tandem high-dose therapy (HDT) followed by autologous peripheral blood stem cell (PBSC)
The conditioning regimen of the first HDT was mitoxantrone 45 mg/m² intravenously on d1 + cytarabine 1000 mg/m² by a 3-hour infusion every 12 hours from d1-4. The conditioning regimen of the second HDT started d30 to d45 after the first stem cell infusion, and consisted of 1200 cGy total body irradiation (TBI) in 6 twice daily 200 cGy fractionated doses with a 800 cGy pulmonary shielding, followed by CBV: carmustine 300 mg/m² intravenously on d4, etoposide 200 mg/m² intravenously on d5-8 and cyclophosphamide 1500 mg/m² intravenously on d5-8.

Locations

Country	Name	City	State
France	Emmanuel Gyan	Tours

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Ouest Est d'Etude des Leucémies et Autres Maladies du Sang GOELAMS	Amgen

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response		end of treatment	Yes
Secondary	overall survival disease free survival		10 years after treatment	Yes